fda milk pasteurization requirements

Contamination of the milk or milk product may occur through contact with the outside of the dry ingredient container. Air valves, including the FDD, are pulsated during CIP cycle. (PMO, Part I, Definition S). Search & Navigation straight edge ointment jars and immediately close to avoid drying. When used to describe a dairy ingredient, means that every particle of such ingredient shall have been heated in properly designed and operated equipment to one of the temperatures specified in the table below and held continuously at or above the temperature for the specified time or other time/temperature relationship which has been demonstrated to be equivalent thereto in microbial destruction: Note: products with greater than 10% fat and or added sweeteners shall be pasteurized at 5oF higher. Dairy processors can rely on Eurotherm for the digitization of pasteurization temperature and process data. which is more heat resistant than bovine phosphatase. pL;k|S_pxi8|VW%bt2: TRrX\ LFA!qZRh)U2r2 b(%*%G}:F~ 0fb0ffbc,cxpH^fbb`P R@\$<3XFJ 1!H32lbdbP`S$ \]s0Ab`[}AiP``- { developer resources. Do not routinely sample dry milk products labeled with a USDA shield unless used as a raw material, and there is reason to suspect contamination or adulteration, or a direct observation of contamination was made during inspection or investigating a consumer complaint. Review the volume control records on the use of vitamins. This model milk ordinance, now titled "Grade A Pasteurized Milk Ordinance" (PMO), also provides administrative and technical details as to satisfactory compliance with the ordinance. (PMO, Part II, Section 7, Item 15p). Clean, adequately filtered air should be supplied to product dryers, product coolers, dry product handling equipment and instantizing equipment. All pasteurized milk and milk products, pasteurized whey and condensed milk products shall be stored at a temperature of 45oF or less and maintained there at until further processing. Evaluate the handling and treatment of the condenser cooling water. (4) Characterizing flavoring ingredients (with or without coloring) as follows: (i) Fruit and fruit juice (including concentrated fruit. switch to eCFR drafting site. Pasteurization process regulations such as the U.S. Department of Health and Human Services, Public Health Service and FDA . FDA's primary function under the Federal/State Milk Safety Cooperative Program (IMS Grade A products) is to provide technical assistance to the states in the implementation and enforcement of their milk regulations. The same subdivisions may be used for WIA-butyric acid determinations. Recommendations of the United States Public. Consider the following: Plant air supply systems should provide clean, adequately filtered air for all post-pasteurization processing rooms in which the finished product is exposed to the air, i.e. Salmonella, phosphatase, penicillin) as appropriate. Obtain sources of Vitamins A & D and other optional ingredients. Sec. Pasteurization Program. The suitability of finished product containers. Composition - See section 2b. Verify that needed corrections were made. Condensed milk should be held at 45oF or less, but it can be held up to 1 hour at 45oF - 135oF or two hours at 135oF - 165oF. *If a lot or mark contains fewer cases than the number of subs specified, collect 1 sub from each case with one or more additional subs per case to provide the minimum number of subs required. Instructions for sampling is found in the IOM or as follows: Restrict sampling during inspections to instances where there is a clear-cut food additive violation. The name of the food shall be accompanied on the label by a declaration indicating the presence of any characterizing flavoring, as specified in 101.22 of this chapter. In the case of 1-lb. PART 1240 -- CONTROL OF COMMUNICABLE DISEASES, Subpart D - Specific Administrative Decisions Regarding Interstate Shipments. All circuits washed daily or as required by use; and. The pasteurizer side pressure should remain higher than the raw side at all times. Identify each subdivision with corresponding churn mark and the determination to be made. 0000009175 00000 n If you would like to comment on the current content, please use the 'Content Feedback' button below for instructions on contacting the issuing agency. State and local regulatory agencies are responsible for the enforcement of sanitation requirements on dairy farms, in processing plants, dry milk plants, receiving and transfer stations (establishments where raw milk or cream is received for further transport). 0000004160 00000 n Salmonella - Salmonella is a pathogen that, when consumed, can cause an infection. (eg: Give special attention to the flow diversion valve and the thermal limit controller (recording thermometer). Be alert for careless handling of powdered ingredients (vitamins, flavors, etc.) The guidance in this section is applicable to other dried whey products, i.e., cheese, butter, whey, caseinate, etc. See Appendix H, "Indicating Thermometers used in Storage Tanks", and "Recording Thermometers Used in Storage Tanks". 19, 1982; 49 FR 10090, Mar. user convenience only and is not intended to alter agency intent Receiving hoses should be clean, protected and cleaned daily after the last truck of incoming raw milk or cream has been received. Evaluate filtration and clarification steps. 0000048576 00000 n Proper use requires flushing these agents from the system. Always "bracket" each piece of equipment to pinpoint contamination source. Check for evidence of milk leaking from the pasteurizer, piping and other processing equipment. Evaluate product flow through the plant and determine whether there is unnecessary product movement between areas which may increase the likelihood of cross-contamination. Single service items are replaced daily. Product must be maintained at 45F (7.2oC) or below prior to and after pasteurization. Observe scheduled plant and equipment cleanup including plant start-up and shut down procedures. assure the proper pasteurization of milk and milk products. Insert trier straight down at points 2 inches from the edge of the semicircular surface as follows: Composite 6 trier fulls using aseptic techniques taken straight down from top to bottom at equidistant points grouped around the center of the bag. [42 FR 14360, Mar. (b) Except as provided in paragraphs (c) and (d) of this section, the terms "pasteurization," "pasteurized," and similar terms shall mean the process of heating every particle of milk and milk product in properly designed and operated equipment to one of the temperatures given in the following table and held continuously at or above that temperature for at least the corresponding specified time: 1 If the fat content of the milk product is 10 percent or more, or if it contains added sweeteners, the specified temperature shall be increased by 5 deg.F (3 deg.C). This web site is designed for the current versions of The information on this page is current as of Jun 07, 2023. (c) Eggnog shall be heated to at least the following temperature and time specification: (d) Neither paragraph (b) nor (c) of this section shall be construed as barring any other pasteurization process that has been recognized by the Food and Drug Administration to be equally efficient in the destruction of microbial organisms of public health significance. Pasteurizers, 2 - Milk to Milk Regenerator Flow Diagram, Attachment 3 - Summary of Specifications For, Standardized Cheese & Cheese Products -- five pages, Grated American cheese food-Sap sagago cheese, Skim milk cheese for manufaturing- Part-skim spiced cheese, Pasteurized process cheese to Pasteurized process pimento cheese, Pasteurized blended cheese to Pasteurized process cheese spread, Pasteurized process cheese spred with fruits etc. contact the publishing agency. Filled Milk Act, 21 U.S. C. Sections 61-64, enacted March 4, 1993. %PDF-1.6 % Evaluate equipment construction characteristics for assurance that static accumulations are controlled, particularly in fluid milk drying and conveying equipment, sifters, rollers, drum, sanitizers. here. During butter inspections place major emphasis on filth and decomposition in cream and/or milk as well as plant sanitation. Large Bulk Containers, Holding Vats, Mixing Bins. Are the filters reusable or disposable? Verify that box dryer(s) are being sanitized as described in the DMO. Vat pasteurization is used primarily in the dairy industry as a means of preparing milk in the processing of cheese, yogurt, and other common food products. If you want to discuss an . clothing prior to entering the drier for cleaning or other purposes. The official AOAC method requires that the commercial bulk containers be first stirred thoroughly for at least five minutes with a dairy stirrer (a 5 1/2" perforated concave metal disk attached to a 27" metal rod as a handle. Cover protecting product (PMO, Part II, Section 7, Item 16p (A)). "Published Edition". If you have comments or suggestions on how to improve the www.ecfr.gov website or have questions about using www.ecfr.gov, please choose the 'Website Feedback' button below. 21 CFR Sections 1/10; 101; 108; 110; 113; 131; 130; 133; 173.310; and 178.1010. Post-pasteurization contamination must be given close scrutiny. (PMO, Part II, Section 7, Item 16p (A) (3)). If surge tanks or balance tanks are used between the evaporator and the drier, such tanks shall hold the product at a temperature of 150oF or more, or shall be completely cleaned at a minimum of once every 4 hours of operation or less. Color Additives - Two pounds taken at random from the lot (see IOM Sample Chart 9). Single service articles are those having a milk contact surface, used in the processing of milk, and intended for one use only. 0000003054 00000 n citations and headings Pasteurization of milk was adopted decades ago as a basic public health measure to kill dangerous bacteria and largely eliminate the risk of getting sick from one of the most important staples. Sample must be refrigerated. If inspectional evidence indicates slow acid formation, collect a 1/4 pound sample aseptically from each vat of cured cheese available (with a maximum of 5 vats) immediately prior to removal of the cheese from the vat for hooping and pressing. Verify that all farm bulk tanker trucks unloading raw milk at the plant are screened for beta lactam drug residues prior to processing the raw milk. (PMO, Part II, Section 7, item 20r). 0000011869 00000 n Staphylococci die rapidly after cheese has been pressed and for this reason sample only freshly made cheese. Temperature of the product never exceeds 45oF prior to packaging. endstream endobj 389 0 obj <>/Outlines 53 0 R/Metadata 71 0 R/PieceInfo<>>>/Pages 70 0 R/PageLayout/OneColumn/OCProperties<>/OCGs[390 0 R]>>/StructTreeRoot 73 0 R/Type/Catalog/Lang(EN)/LastModified(D:20091201105022)/PageLabels 68 0 R>> endobj 390 0 obj <. Exception: acid type whey with a titratable acidity of 0.40% or above, or a pH of 4.6 or below. **Collect two-pound subdivisions to provide 1/2 lb. Bulk Containers - Collect samples from bulk containers using aseptic technique. Use the last inch to plug the hole. (k) Milk term ``milk'' shall include the following: . In addition to the instructions and information provided in IOM Subchapter 530 regarding food inspections, direct attention to the following areas when conducting inspections of cheese producers. Rollers and collectors should be located in a room separated from other operations to prevent airborne contamination. Choosing an item from 1240.61 Mandatory pasteurization for all milk and milk products in final package form intended for direct human consumption. The ordinance is incorporated by reference in federal specifications, for procurement of milk and milk products served on interstate carriers, and is recognized by public health agencies and the milk industry as a national standard for milk sanitation. As a general rule, collect a representative sample of the same amount of finished food as would be required for a filth analysis. How? If possible, each subsample should represent one such code (vat). Sample the square root of the number of bulk containers in lot. All whey for condensing is maintained at a temperature of 45oF or less; or 145oF or greater until processed. (c) Ultra-pasteurized when used to describe a dairy product means that such product shall have been thermally processed at or above 280 deg.F for at least 2 seconds, either before or after. The vacuum breaker should be installed in the proper location and 12 inches above the highest raw milk in the system. 1240.61 Mandatory pasteurization for all milk and milk products in final package form intended for direct human consumption. Report the amount of milk which an exhibit represents. If direct injection into product, steam should be properly filtered, piped and trapped. Pasteurization shall mean the process of heating every particle of milk or milk product, in properly designed and operated equipment, to one of the temperatures given in the following chart and held continuously at or above that temperature for at least the corresponding specified time: *If the fat content of the milk product is 10% or more, or if it contains added sweeteners, the specified temperature shall be increased by 3oC (5oF). The (1) Milk is the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows. Certified lots not designated for sampling are to be released without delay, unless the lot was sampled for some other reason than those attributes specifically covered by the MOU. Check for cross-connections between potable water and: product, CIP system(s), boiler water feed tank, i.e. Collect subdivisions of 1/2 pound or 1 print, if in 1-lb prints. Samples should be held and shipped under refrigerated conditions. Review firm records for butterfat analysis and report disposition of any low fat churns and excessive overruns. * (PMO, Part II, Section 7, Item 16p (B) (1)(2)). Deviations from the PMO can be listed as objectionable conditions if the procedures and standards in use at a firm are not deemed to be equivalent to those in the PMO. The in-page Table of Contents is available only when multiple sections are being viewed. Inlet piping and valving shall be of proper construction (PMO, Part II, Section 7, Item 16p (A) (4)). (c) Optional ingredients. Evaluate the source and nature of the water supply and any subsequent treatment. This is an automated process for . Guidelines. There is a single-service final filter immediately prior to use. Place cores in suitable size (4 oz.) 0000002695 00000 n Report time and temperature of this process if applicable. Document any deficiencies in frequency or testing. Size of Lot - up to 50 cases, if container net weight is equal to or less than 340 grams (12 oz) collect 24 containers, two subs from each of 12 cases. 0000008820 00000 n Give special attention to the flow diversion device and the thermal limit controller as well as the timing device in the system. Retail Containers - Sample the square root of the number of containers in the lot but not less than 6, nor more than 18 in duplicate (minimum sub size is 8 oz.). Quality control records should also be checked for abnormal milk (e.g., somatic cell counts over 1 million per ml.). The contents of damaged containers of dry milk should be reconstituted, re-pasteurized, and processed if intended for food use and if no visible extraneous material was introduced into the product. (1) The following terms shall accompany the name of the food wherever it appears on the principal display panel or panels of the label in letters not less than one-half the height of the letters used in such name: (i) If vitamins are added, the phrase "vitamin A" or "vitamin A added", or "vitamin D" or "vitamin D added", or "vitamin A and D" or "vitamins A and D added", as is appropriate. The Dairy Division of NASDA requests USDA, Dairy Standardization Branch to conduct a study, based on food safety criteria, to determine appropriate cooling temperature requirements for can milk recommended for adoption by state regulatory agencies. gassy cheese or off flavors). A sanitary check valve is located downstream from the final filter to prevent product from contaminating the filter and air piping. Always include as one of your in-line subs the first material through the dryer. Electronic Code of Federal Regulations (eCFR). Review results of official state samples, if taken. Consider the following: Determine plant policy on visitors and personnel traffic through processing and storage areas. Residual phosphatase activity is the test commonly used to indicate the pasteurization effectiveness. In every plant inspected collect in-line factory samples where conditions exist which may harbor Salmonella or where Salmonella or other bacterial contamination is suspected (see IOM Sample Schedule, Chart 1). Record the code number on the subsample jar. (PMO, Part II, Section 7, Item 16p (A)(1)(c)). 0000008783 00000 n Evaluate the quality control program. The document does not bind FDA, and does not confer any rights, privileges, benefits, or immunities for or on any person(s). Microsoft Edge, Google Chrome, Mozilla Firefox, or Safari. Equipment used for the manufacturer of dried dairy products should not be used in drying other products unless effectively cleaned and sanitized prior to the drying of the dairy products. Milk that is in final package form for beverage use shall have been pasteurized or ultrapasteurized, and shall contain not less than 8 (b) Except as provided in paragraphs (c) and (d) of this section, the terms pasteurization, pasteurized, and similar terms shall mean the process of heating every particle of milk and milk product in properly designed and operated equipment to one of the temperatures given in the following table and held continuously at or above that temperature for at least the corresponding specified time: 1 If the fat content of the milk product is 10 percent or more, or if it contains added sweeteners, the specified temperature shall be increased by 5 F (3 C). Verify the product is held at the minimum pasteurization temperature continuously for a minimum of 30 minutes. (DMO, Appendix A.). Background and more details are available in the Properly installed and maintained flow diversion device (FDD), divert line and leak detect line. A milkstone buildup indicates improper cleaning. Pasteurizing, processing, cooling and packaging of milk and milk products should take place in a room separate from cleaning and sanitizing facilities for milk tank trucks, and other areas in which raw milk and raw milk utensils are handled. It must be checked and sealed by authorized regulatory officials. If net weight is greater than 340 grams (12 oz), collect 24 containers, one sub from each of 24 cases. The balance tank should be of proper design and construction. Do not add moisture adhering to the outside of the trier. The word "vitamin" may be abbreviated "vit.". Three average trier fulls will usually provide slightly more than the 1/2 pound required for the subdivision. (PMO, Part II, Section 7, Standards). If sample is collected from bulk, include open and closed controls. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). Pasteur developed pasteurization in 1864. Collect Official Samples in instances where there is a clear-cut additive violation. This field test is applicable to milk only; not to cheese or curd because of interfering substances. NOTE: A churn mark is an identification of each batch made. Check the vacuum breakers and positive shut-off valves in the lines between the pasteurizer and evaporators. Be alert for condensate formation throughout the plant and for optimum moisture and temperature conditions conducive to Salmonella growth in static material. 0000001627 00000 n Condensed whey shall be cooled during the crystallization process to 45F or less within 18 hours of condensing. Review the records of vitamin testing if products produced are vitamin fortified. If the firm furnishes employees disposable clothing for these areas, it should be used. Sec. Raw milk should be protected from outside contamination. The goal of the thermal process is to sterilize foods and beverages like milk, juice, dressing and yogurt, while ensuring that they keep their sensory appeal and become shelf-stable products. In no case should this time period for submission of the samples exceed 96 hours. When the product is packed in barrels or other bulk containers: remove the head; composite 6 trier fulls from each container for each subsample; place in a sterile, clean, dry container. (Polyethylene bags are not to be used for cheese sampled for fat and moisture determinations unless the sample can be held under refrigeration until submitted to the laboratory.). PMO, Part 1, Definition S; Attachment 4 for acceptable pasteurization times and temperatures; and Attachment 1 for pasteurizer evaluation. [52 FR 29514, Aug. 10, 1987, as amended at 57 FR 57344, Dec. 4, 1992], Note: If you need help accessing information in different file formats, see pumps, valves, thermometers, etc.) The air supply system should be maintained in a clean, sanitary, and efficient operating condition including changing or cleaning of filters as often as necessary. Evaluate equipment cleanup procedures. If short eight, sample as for fat. Decades ago, pasteurization of milk was adopted as a basic public health measure to kill dangerous bacteria. The phosphatase test is not specific to bovine phosphatase, but may detect phosphatase from other sources such as vegetative cells, mold, etc. Approved by the FDA or With the Concurrence of the FDA-the equipment, processes, policies, decisions or any other items referenced are consistent with published requirements, policies, standards and recommendations contained in publications in the Pasteurized Milk Ordinance (PMO), Procedures Governing the State-Public Health Service/Food and . You can learn more about the process 0000007636 00000 n 0000007901 00000 n Proper safeguards should be taken to prevent condensation from entering the product. Milk may have been adjusted by separating part of the milkfat therefrom, or by adding thereto cream, concentrated milk, dry whole milk, skim milk, concentrated skim milk, or nonfat dry milk. Determine if the source of the air is filtered. 0000007235 00000 n Results should be recorded on FDA form 2359 b or equivalent (PMO, Appendix M). If the lot is readily available for re-sampling, preliminary samples of fewer subdivisions may be collected where special circumstances so dictate. (PMO, Part II, Section 7, Item 5p). Refer to IOM Subchapter 530 for general instructions on conducting food inspections. If cheeses are being made which may, in lieu of pasteurization, be aged for a specific time and minimum temperature, and the plant has elected this option, or if aging is required regardless of pasteurization, check storage practices including the following: Pasteurized process cheeses are required to be heated during preparation to a temperature not less than 150oF for not less than 30 seconds. Observe and evaluate the packaging operation to determine: Evaluate the safeguards and precautions in the filling and packaging areas to avoid product contamination, i.e., the method of final weight adjustment and the sanitary handling of packaging containers at this point. Note: See Attachment 4 for eggnog. will bring you to those results. No cross-connection between CIP and product (PMO, Part II, Section 7, item 15p (B)). The flow diversion device (FDD) should move to divert position. 49 CFR 172.101 Shipment of unpasteurized almonds to markets outside of North America are allowed only if the product is properly labeled as "unpasteurized," and should be subjected to an appropriate process prior to . 0000008969 00000 n If filth only is to be determined, the sample need not be refrigerated. It is not an official legal edition of the CFR. Displaying title 21, up to date as of 6/23/2023. The frequency pen should go to the divert position. Note: This document is reference material for investigators and other FDA personnel. (PMO, Part II, Section 7, item 16p(D) and Attachment 2). Separate cleaning equipment should be used exclusively for the drying system and should be stored properly. The name of the food is "milk". Seal each sub separately. We recommend you directly contact the agency associated with the content in question. Accessibility of hand washing facilities to processing and packaging areas. (3) Nutritive sweeteners. Review vitamin usage logs which record actual and estimated vitamin usage. If a positive displacement timing pump is used, it should be sealed* at its maximum flow rate by a regulatory agency. Certifications/listings of U.S. manufacturers of single-service containers and/or closures for milk and/or milk products shall be conducted by . The evaluation should consider the following: Determine the identity, strength, and use of sanitizing agents. (d) Methods of analysis. xbbr``b``3 5 Determine what follow-up is made on patrons whose milk is high in sediment. Collect in-plant samples,sediment pads, and other evidence necessary to document insanitary practices and the receipt and use of filthy milk. Review regulatory authority tests on pasteurization equipment for compliance with the specification as outlined in PMO, Appendix I, and PMO, Part II, Section 7, item 16p (E)(2). 0000006690 00000 n non-potable water or cooling media, i.e. (1980), which is incorporated by reference. Deviations from the normal phosphatase reaction expected in pasteurized products sometimes occur when HTST pasteurization temperatures exceed 163oF and/or salts such as magnesium chloride are added after pasteurization, [Note: Some of the guidance furnished below is only applicable to certain inspectional situations, consult with your regional/district milk specialist or the Milk Safety Branch to determine applicability to firm being inspected.]. Collection reports and records should arrive at the laboratory with or ahead of the sample. This time period does not include vat filling, preheating, emptying or cooling steps/times. If you have questions or comments regarding a published document please Although the PMO does not have the force of regulations, it provides procedures and standards of general applicability that are acceptable to FDA. Fully document any insanitary condition noted with appropriate photographs, exhibits, etc. "3-A Accepted Practices for the Sanitary Construction, Installation, testing and Operations of HTST Pasteurizers", CPG 7158.01, MOU with the National Conference on Interstate Milk Shipments Relating to Interstate Milk Shipments. Use about 3/4 inch of rind portion or core to reseal hole." These data demonstrate quite clearly that there is much room for improving milk quality . (PMO, Part II, Section 7, Item 5p). (2) The following terms may appear on the label: (i) The word "pasteurized" if the food has been pasteurized. 0000004379 00000 n or larger solid prints, deliver entire print in person if laboratory is easily accessible otherwise submit entire print in dry glass jars. CIP solution completely drained prior to packaging. You are using an unsupported browser. Spray dryers should be a continuous discharge type, easily cleanable and should be cleaned and inspected at least daily. Comments or questions about document content can not be answered by OFR staff. Explain the exhibits with reference to the probable amount of cream involved, whether it was the same cream you examined, and what churn numbers are related to the exhibits. Use aseptic technique when sampling from bulk. Ascertain scope of Salmonella testing of water supply, and the air supply, at critical processing points, in the plant environment, and in finished products. The vat pasteurizer must comply with construction requirements. The pasteurization of milk products is a heavily regulated process and is critical to public health and safety. Find out below. Regulated Product(s) to end, 4 - Pasteurizer Chart for Fluid Milk and Other Dairy Products. There are usually one or more in-line filters in addition to the dump tank screen which will remove gross material. Take precautions to assure that samples are properly refrigerated during shipment and arrive at the laboratory promptly and in good condition. Use the following formula for sealing compound: By mixing and heating white petrolatum and paraffin (1:1). Always wear a clean lab coat or clean white coveralls when inspecting a dairy processing plant. The .gov means its official.Federal government websites often end in .gov or .mil. Enhanced content is provided to the user to provide additional context. [52 FR 29514, Aug. 10, 1987, as amended at 57 FR 57344, Dec. 4, 1992]. Bagged Material & Bulk - Aseptically collect 12 - 1 lb. But, how did we get there and what does pasteurization mean? The PMO provides uniform regulations for the dairy industry that are created by the dairy industry, government, and academic representatives. Each subdivision should consist of at least 1/2 pound exclusive of claimant's portion. Please do not provide confidential Conduct a phosphatase test on pasteurized milk using the method furnished with the field phosphatase test kit. Processing use of evidence-based methodologies, including pasteurization, to prepare safe milk for recipients. Tests must be conducted in accordance with PMO, Appendix I. Product in storage must be protected from external contamination (PMO, Part II, Section 7, Item 5p). In the past, use of unpasteurized milk was justified on the belief that the curing process inactivated all pathogens. 15, 1977, as amended at 47 FR 11822, Mar. Refer to IOM Subchapter 530 for general instructions on food inspections. Check the firm's quality control records for drug residues in milk. which may contribute to product contamination.

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